(173 days)
Not Found
No
There is no mention of AI, ML, or related concepts in the provided text.
No
The provided information does not describe any therapeutic function or intent for the device. It only mentions "nasal passages" as an anatomical site.
No
The provided information does not contain an "Intended Use / Indications for Use" section, which would typically specify if the device is intended for diagnosis. Without this information, we cannot confirm it's a diagnostic device.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device.
Based on the information provided, it is not possible to determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The provided text lacks the key information needed to classify a device as an IVD. An IVD is a medical device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Crucially, the "Intended Use / Indications for Use" section is "Not Found". This is the primary section that would describe how the device is used and what it is intended to diagnose or measure, which is essential for IVD classification.
- Other relevant sections like "Device Description" and performance studies are also "Not Found".
Without knowing the intended use and how the device interacts with biological samples, we cannot determine if it fits the definition of an IVD. The mention of "nasal passages" as an anatomical site suggests it might be related to the respiratory system, but this alone doesn't confirm it's an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3900 Nasal dilator.
(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
FEB 1 2 1997
510K SUMMARY
Product Name: BREATHE FIT™
Sponsor's Name: Cambridge Associates P.O. Box 2048 Fort Lee, NJ 07024
SUBSTANTIAL EQUIVALENCE
Breathe Fit™ is substantially equivalent to another commercially available product which uses similar methodology for improving nasal air flow to allow freer breathing.
Manufacturer : CNS, Inc. Product: Breathe Right -A drug free, non-prescription adhesive device that mechanically improves nasal breathing by opening the nasal passages.